Proper and unbiased testing is an integral part of any manufacturing process.  And this is especially vital in the pharmaceutical industry.  Because of the pharmaceutical industry’s inherent need for quality control, at the highest levels, a new form of testing was required to ensure the highest quality products available.  This form of testing is known as third-party testing, where an independent third party testing operation, test the quality of the product in question, off-site at one of their testing plants.  This ensures that both the government and the company itself cannot affect the testing, neither positively nor negatively, in any way.  This ensures a true unbiased assessment on the quality of the product.

Sounds pretty simple, right?  Well, yes it does, in theory, but when it comes to testing combination products, things get a bit more complicated.  Let’s clarify this.  Before the FDA tests a product or takes the product to a third party testing operation, each FDA product is first assigned to a particular center within the FDA that will have primary jurisdiction over the product.  Combination products, on the other hand, are assigned to different centers, based on their “Primary mode of action”, which means their primary purpose.  However, making this determination can sometimes be difficult and confusing.

Before these products can be tested either by the government, or a third party testing group, it has to be decided under what jurisdiction it will fall under.  Due to the large variations between the different levels of FDA research and testing departments, there are huge variations in terms of time and money required for FDA approval.  Because of this, a combination product’s designation to a particular department could have a major impact on the company’s ability to finance the product.  Because of this large variation, it has become a tremendous financial burden to some drug manufacturers, and they want a change.  And the change they want is third-party testing.

Although the FDA’s feelings about this are mixed, they are not altogether opposed to looking into the idea.  But, to even be able to test combination products at third-party testing sites, each product needs to have these same criteria.  In order to perform product testing on combination products certain standards are needed to establish what ingredients or specific compounds, they are going to test.  If they are not specific in explaining what they need testing, then reliable testing can only be successful in testing single name brands.  Not only this, but many testing standards are different at different third party testing sites, which can complicate matters even more.

As the FDA and the pharmaceutical companies try to reach an agreement on this matter, much more standardized testing methods need to be instituted before any real progress is made.  If your company would like to know more about third-party testing methods of combination products, then contact your local pharmaceutical consulting firm for more information.

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